A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder

Roche

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: RO4917838; Drug: Standard Antipsychotic Therapy; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01116830

BP22445

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive either RO4917838 (10 milligrams [mg] daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia or schizoaffective disorder (based on screening tests)
• Medically stable for 1 month and psychiatrically stable without symptom exacerbation for 6 weeks prior to baseline
• On stable treatment with a maximum of 2 antipsychotics

Exclusion criteria

• Change in regimen for any psychotropic or sleep medication within 1 month
• Treatment with more than (>) 1 mood stabilizer or antidepressant
• Use of clozapine within 2 months
• Bipolar disorder, or more than mild anxiety disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Standard Antipsychotic Therapy

Drug: Placebo

RO4917838

Experimental group

Treatment:

Drug: RO4917838

Drug: Standard Antipsychotic Therapy